Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome
1 other identifier
interventional
49
1 country
1
Brief Summary
This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2016
CompletedFirst Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2017
CompletedSeptember 6, 2019
September 1, 2019
1.3 years
April 7, 2017
September 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Questionnaire that examines upper limb function
10 minutes
Secondary Outcomes (7)
Goniometer
1 minute
CRPS severity score (CSS)
20 minutes
skin rolling test
1 minute
trigger point examination
5 minutes
NPRS
1 minute
- +2 more secondary outcomes
Study Arms (2)
CRPS patients
EXPERIMENTALCRPS patients that will be examined for trigger points in the thoracic muscles. 10 out of the 23 will also be included in the intervention stage and will recieve a month of conventional physiotherapy, and a month of conventional physiotherapy with addition of massage to the thoracic area.
healthy controls
NO INTERVENTIONhealthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)
Interventions
a 15 minutes thoracic massage will be added to the regular physical therapy treatment
Eligibility Criteria
You may not qualify if:
- Tumors
- Participation in another interventional clinical trial.
- History of major psychiatric or neurological illness (like stroke).
- Rheumatoid arthritis or other major rheumatologic disorders.
- Fibromyalgia or any other systemic illness.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reuth Rehabilitation Hospital
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Jeaques Vatine, Prof
Reuth Rehabilitation Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 12, 2017
Study Start
June 6, 2016
Primary Completion
September 17, 2017
Study Completion
September 17, 2017
Last Updated
September 6, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share